Bioequivalence and Bioavailability Forum • administered dose for drugs dosed per kg body weight

administered dose for drugs dosed per kg body weight [Design Issues]

posted by Helmut – Vienna, Austria, 2014-08-11 13:14 (4334 d 13:01 ago) – Posting: # 13363
Views: 9,416

Hi Luv,

❝ You can Check the EMA BE requirment for Capecitabine.

I think that EMA’s draft guidance can easily be misinterpreted (see my remarks at the end of this post). Maybe the guidance’s wording is just ambiguous. The 500 mg strength is OK, but should not be interpreted as the suitable dose – which should still be calculated according to the common posology.

—
Dif-tor heh smusma 🖖🏼 Довге життя Україна!
Helmut Schütz

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Complete thread:

administered dose for drugs dosed per kg body weight BarbaraM 2014-08-07 14:40
- administered dose for drugs dosed per kg body weight ElMaestro 2014-08-07 15:01
- Definition of BE (EMA) Helmut 2014-08-07 15:12
  - Definition of BE (EMA) BarbaraM 2014-08-07 16:31
    - Dosing low or as per 4.2 ElMaestro 2014-08-07 17:42
    - Definition of BE (EMA) Dr_Dan 2014-08-11 00:10
      - Patients or healthy subjects? Helmut 2014-08-11 11:02
- administered dose for drugs dosed per kg body weight luvblooms 2014-08-11 06:56
  - administered dose for drugs dosed per kg body weightHelmut 2014-08-11 11:14
    - administered dose for drugs dosed per kg body weight luvblooms 2014-08-12 06:28
      - Patients or healthy subjects… Helmut 2014-08-12 12:23